Transparency must be a focus of F.D.A. recall procedures

Aug. 16, 2012
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by Jay Sjerven

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A report issued last month by the Government Accountability Office questioned whether the Food and Drug Administration was prepared to order a food recall in a manner that was sufficiently clear and understandable to food companies and consumers.

The F.D.A. Food Safety Modernization Act (F.S.M.A.) gave the F.D.A. the authority to order a company to recall a food product determined to be a threat to health in the event the company refused to voluntarily do so. The recall authority has not been used since the F.S.M.A. took effect in January 2011. And it was uncertain when or even if the F.D.A. will actually find it necessary to use the new authority given the high stakes involved in a company refusing to abide by a request that it voluntarily recall an adulterated or misbranded food. But with food safety a pressing national concern, the G.A.O. asserted it was important the F.D.A. be guided by a known plan and procedures in the event the agency found it necessary to order a food recall.

The report titled “F.D.A.’s food advisory and recall process needs strengthening” addressed three basic areas of concern: the need for a well understood plan with procedures that would be employed if the F.D.A. orders a food recall; communications challenges in advising the public about food recalls or outbreaks of foodborne illness; and what might be done to compensate food producers in the case they were ordered to recall a food in error.

The G.A.O. said the F.D.A. would be expected to employ the same basic process in an ordered food recall that it uses in the case of its non-food product ordered recalls (pharmaceuticals and medical devices) and that other federal agencies use in ordering recalls of products under their charge. The process would include determining that available evidence of a threat meets a standard of proof to order a recall, offering a company the opportunity to voluntarily recall a product before a recall order is issued, and providing the company with an opportunity to challenge a recall decision.

“F.D.A. has internal procedures describing the steps it will take to order a food recall, although these procedures are not yet public, and the agency has not issued regulations or industry guidance to clarify its ordered food recall process,” the G.A.O. said.

The G.A.O. noted that food industry stakeholders in June 2011 asked the F.D.A. how it would implement its new recall authority indicating they would benefit from more clarity. Of particular interest was how the agency would weigh evidence in determining whether a recall was necessary.

“Without publicly available procedures, regulations or industry guidance on how the agency will implement its authority — including how the agency will weigh evidence on whether a recall is necessary — the agency cannot ensure that it applies practices uniformly or consistently or that it provides clear information for the food industry to follow or consumers and the public to understand,” the G.A.O. said.

The G.A.O. report provided four recommendations for F.D.A. action with regard to the ordered recall process. First, the F.D.A. should document and make public its process for ordering food recalls. Second, the agency’s process for ordering recalls should be documented in regulations or guidance to the food industry. Third, the F.D.A. should document definitions for categories of ordered recalls in the agency’s central recall database (the G.A.O. found a lack of clarity in this regard in the F.D.A.’s ordered recall process for non-food products). And fourth, the F.D.A. should identify and implement ways to improve information sharing among its own databases.

The F.D.A., in response to these recommendations, said it has completed an interim standard operating procedure (SOPs) for ordering food recalls and added, “F.D.A. is currently in the process of incorporating these SOPs formally into the Regulatory Procedures Manual (R.P.M.). F.D.A. anticipates that the procedure for ordered food recalls will be available in the R.P.M. by fall 2012.”

The F.D.A. agreed it was important to provide information to stakeholders on how it will weigh evidence on whether a recall is necessary and pointed out it has convened working groups that are considering options for providing such information. The agency’s comment did not refer to a possible guidance to industry.

The agency said it was updating its central recall database, the Recall Enterprise System, to more adequately reflect the different types of recalls, voluntary and mandatory, that are documented in the system. It said the changes to the RES should be completed by the fall of 2012.

The F.D.A. faces several communications challenges when advising the public about food recalls or outbreaks of foodborne illness, ranging from balancing technical accuracy with timeliness of communications to coordinating messages with other agencies to meeting the needs of diverse audiences, the G.A.O. noted.

“The agency has taken steps to begin meeting these challenges but has yet to fully address recommendations from G.A.O. and others to fashion a comprehensive food recall communication policy and related implementation plans,” the G.A.O. said.

The G.A.O. report raised the question of how food producers might be compensated in the event of an erroneously ordered food recall or an erroneous food warning advisory. The F.D.A. had no response to that section of the report and was not authorized to provide any such compensation under existing legislation.

The G.A.O. pointed out the judicial process was an existing means for a company to seek compensation.

“At least one company — a South Carolina tomato farm — filed suit against the federal government for F.D.A.’s 2008 warning of an apparent link between eating raw tomatoes and a Salmonella outbreak,” the G.A.O. noted. “The government responded by asserting, among other things, that F.D.A. is immune to the particular claim.”

The G.A.O. acknowledged the judicial process was time-consuming and costly for those seeking compensation.

Any other mechanism for seeking compensation would require legislation. Proposed mechanisms included a dedicated federal program and federal government-subsidized insurance. The G.A.O. said individuals it interviewed in this regard said that a potential advantage of a dedicated program would be assurance to the industry that a mechanism to seek compensation would be available, but a potential disadvantage would be that in lean budget times, funding for such a program may be difficult to obtain.

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